Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K170085 |
Device Name |
SONON Ultrasound Imaging System, Model: 300L |
Applicant |
HEALCERION CO., LTD |
804HO, 38-21, DIGITAL-RO 31-GIL, |
GURO-GO |
SEOUL,
KR
08376
|
|
Applicant Contact |
JAEYEOB JUNG |
Correspondent |
THE ALLIS LAW FIRM, PLLC |
2437 BAY AREA BLVD., #30 |
HOUSTON,
TX
77058
|
|
Correspondent Contact |
CARMELINA G. ALLIS |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/10/2017 |
Decision Date | 10/12/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|